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NCT06626516 · ClinicalTrials.gov registry record · Phase 1
Tebentafusp-tebn With LDT in Metastatic UM
A Phase 1 study of Metastatic Uveal Melanoma, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT06626516: Recruiting Phase 1 study of Metastatic Uveal Melanoma, sponsored by Thomas Jefferson University.
NCT06626516 is a Phase 1 study of Metastatic Uveal Melanoma that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 109 participants, below the 125-participant average among 14 other Metastatic Uveal Melanoma trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06626516, a Phase 1 study of Metastatic Uveal Melanoma, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden. In Part 2, the study will investigate the efficacy of tebentafusp-tebn in combination with TACE in patients with bulky hepatic disease.
Primary Outcome
Adverse events (AEs) according to NCI CTCAE Version 5.0. Safety and tolerability data will be presented by treatment arm using the safety population. Safety data will be summarized descriptively and will not be formally analyzed. AE presentation will include incidence, severity, and relationship to study drug.
Conditions Studied
Interventions
- DRUG BCNU
- DRUG Tebentafusp-Tebn
- DRUG GM-CSF (Sargramostim)
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2025-10-15 |
| Est. Completion | 2032-08 |
| Phase | Phase 1 |
What NCT06626516 shows while recruiting
NCT06626516 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 125-participant average among 14 other Metastatic Uveal Melanoma trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Metastatic Uveal Melanoma appearing as the primary indexed condition, and to 3 interventions - of which BCNU is the first listed.
NCT06626516 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06626516 about?
NCT06626516 is a clinical study titled "Tebentafusp-tebn With LDT in Metastatic UM". This study is a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate ...
What is the current status of trial NCT06626516?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2025-10-15. Estimated completion is 2032-08.
What conditions does trial NCT06626516 study?
This clinical trial studies the following conditions: Metastatic Uveal Melanoma.
What interventions are being tested in trial NCT06626516?
The interventions under investigation include: BCNU (DRUG), Tebentafusp-Tebn (DRUG), GM-CSF (Sargramostim) (DRUG).
Who is sponsoring clinical trial NCT06626516?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06626516 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06626516's enrollment target sits among peer trials
109 5th of 14 higher than 10 of 14 other Metastatic Uveal Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Uveal Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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